[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Proposed Rules]
[Pages 550-551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-105]
[[Page Unknown]]
[Federal Register: January 5, 1994]
VOL. 59, NO. 3
Wednesday, January 5, 1994
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 318
[Docket No. 92-029P]
RIN 0583-AB66
Sodium Citrate as a Tripe Denuding Agent
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat inspection regulations to permit the use of
sodium citrate in solution to denude beef stomachs of mucous membranes.
In 1990, a manufacturer of processing aids and other direct food
ingredients petitioned the Food and Drug Administration and FSIS to
approve the use of several compounds, including sodium citrate, for use
in denuding tripe. FSIS has reviewed the data and other information
submitted by the petitioner and has determined that the proposed use of
sodium citrate would not result in product adulteration or misbranding.
The proposed regulation would make available to meat processors an
additional, alternative tripe-denuding formulation that would contain
sodium citrate as an ingredient. The sodium citrate solution would be
as effective as existing tripe-denuding agents, but would be less
objectionable to workers than the agents now in use. The sodium
citrate-containing formulation would contribute to improved tripe
production.
DATES: Comments must be submitted on or before March 7, 1994.
ADDRESSES: Written comments to: Policy Office, Attn. Diane Moore, FSIS
Hearing Clerk, room 3171 South Agriculture Building, Food Safety and
Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
FOR FURTHER INFORMATION CONTACT:
Dr. Bill James, Director, Slaughter Inspection Standards and Procedures
Division, Science and Technology, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC 20250, (202) 720-3219.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This proposed rule is in conformance with Executive Order 12866,
and the Assistant Secretary has determined that it is not a
``significant regulatory action.'' This proposed rule: (1) Would have
an effect on the economy of less than $100 million; (2) would not
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health and safety, or State, local or tribal governments or
communities; (3) would not create a serious inconsistency or otherwise
interfere with an action taken or planned by another agency; (4) would
not alter the budgetary impact of entitlements, grants, user fees, or
loan programs or rights or obligations or recipients thereof; and (5)
would not raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or principles set forth in
Executive Order 12866.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing requirements with respect to
premises, facilities, and operations of federally inspected meat or
poultry products, and any marking, labeling, packaging, or ingredient
requirements on federally inspected meat and poultry products that are
in addition to, or different than, those imposed under the FMIA and
PPIA. States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are outside official
establishments for the purpose of preventing the distribution of meat
and poultry products that are misbranded or adulterated under the FMIA
or PPIA, or in the case of imported articles, which are not at such an
establishment, after their entry into the United States. The States
may, however, impose more stringent requirements on such State
inspected products and establishments.
This proposed rule is not intended to have retroactive effect, and
no applicable administrative procedures must be exhausted before any
judicial challenge to the provisions of this rule. However, the
applicable administrative procedures specified in 9 CFR 306.5 must be
exhausted prior to any judicial challenge to the application of the
provisions of this rule, if the challenge involves any decision of an
inspector relating to inspection services provided under the FMIA. The
applicable administrative procedures specified in 9 CFR part 335 must
be exhausted prior to any judicial challenge to the application of the
provisions of this rule with respect to labeling decisions.
Effect on Small Entities
The Administrator has determined that this proposed rule will not
have a significant impact on a substantial number of small entities, as
defined by the Regulatory Flexibility Act (5 U.S.C. 601). The proposed
regulation would make available to meat processors an additional,
alternative tripe-denuding formulation that would contain sodium
citrate as an ingredient. The sodium citrate formulation could be
manufactured and sold in liquid form and used in existing or newly
developed tripe denuding equipment. The sodium citrate-containing
formulation could be used most efficiently in the new equipment and
contribute to improved tripe production. Small establishments could
benefit from the use of the sodium citrate product.
Background
Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS
provides for mandatory inspection of meat and meat food products
shipped in interstate and foreign commerce. The Act prohibits the
addition of any substance to any meat or meat food product that may
render the product adulterated (21 U.S.C. 601). Section 318.7(a)(1) of
the Federal meat inspection regulations (9 CFR 318.7) prohibits the use
of any substance in the preparation of any product unless its use is
approved in Sec. 318.7(c)(4) of the Federal meat inspection regulations
(9 CFR 318.7), which is the chart of substances acceptable for use in
the preparation of products, or unless it is approved elsewhere in the
regulations or it is approved by the Administrator.
In 1990, a manufacturer of processing aids and other direct food
ingredients petitioned the Food and Drug Administration (FDA) and FSIS
to approve the use of several compounds, including sodium citrate, for
use in denuding tripe. Tripe denudation--the removal of mucous
membranes from beef stomachs--is a necessary step in the cleaning and
preparation of tripe for use as human food. FSIS has reviewed the data
and other information submitted by the petitioner and has determined
that the proposed use of sodium citrate would not result in product
adulteration or misbranding.
FDA lists sodium citrate as generally recognized as safe when used
in accordance with good manufacturing practice in an amount not in
excess of that required to achieve its intended effect (21 CFR
182.1751). In an August 24, 1992, letter to the petitioner, FDA
reported this fact and stated that it would have ``no objection to
[sodium citrate's] addition to the tripe-denuding mixture [contemplated
by the petitioner] providing that it is used in accordance with good
manufacturing practice.''1 FDA further stipulated that the sodium
citrate used be of food-grade quality and that the quantity used not be
in excess of the amount reasonably required to accomplish its intended
effect.
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\ \A copy of this letter is available from the FSIS Hearing
Clerk, USDA, 14th & Independence Avenue, SW., room 3175, South
Agriculture Building, Washington, DC 20250.
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FSIS is proposing to amend Sec. 318.7(c)(4) of the Federal meat
inspection regulations to permit the use of sodium citrate as a tripe
denuding agent in combination with other approved agents, in an amount
sufficient to accomplish the intended effect. Use of sodium citrate for
this purpose would be subject to the condition that the substance be
removed from the denuded tripe by rinsing with potable water.
List of Subjects in 9 CFR Part 318
Food additives, Meat inspection.
For the reasons set out in the preamble, 9 CFR part 318 is proposed
to be amended as follows:
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
1. The authority citation for part 318 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
2. Section 318.7(c)(4) would be amended by adding to the chart of
substances, under the Class of substance ``Denuding agents; may be used
in combination. Must be removed from tripe by rinsing with potable
water.'' the substance sodium citrate in alphabetical order as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(c) * * *
(4) * * *
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Class of substances Substances Purpose Products Amount
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Denuding Agents; may be used in Sodium Citrate.... ......do.......... ......do.......... Do.
combination. Must be removed
from tripe by rinsing with
potable water.
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Done at Washington, DC, on December 27, 1993.
Eugene Branstool,
Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-105 Filed 1-4-94; 8:45 am]
BILLING CODE 3410-DM-M
